86904 Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices 

CureTB connects people with TB to 

healthcare services as they move 

between the United States and other 

countries. The program is a 

collaboration between CDC’s Division of 

Global Migration Health (DGMH) and 

the County of San Diego’s Tuberculosis 

Control Program. CureTB collaborates 

with health authorities throughout the 

United States and around the world to 

link people with TB to care at their 

destinations. Health departments, 

healthcare providers, and others seeking 

help in linking patients to ongoing TB 

care in other countries can refer patients 

to CureTB. CureTB has an interagency 

agreement with ICE (Immigration and 

Custom Enforcement) to refer those 

patients with suspected or confirmed 

TB when they are repatriated to their 

countries of origin. 

CureTB collects the following types of 

information: (1) referring entities 

(referring agency and jurisdiction) 

information including name of referring 

person, telephone numbers, fax 

numbers, email addresses; (2) patient’s 

name and last name(s), demographics 

date of birth, gender, address (U.S. and 

outside of the U.S), telephone numbers, 

email address, patient’s contact persons 

including name and telephone number; 

and (3) TB clinical information, 

including diagnostic testing (radiology 

reports, laboratory testing reports, other 

diagnostic methods used, treatment 

regimen and information about 

comorbidities). 

CDC is requesting OMB approval for 

an additional three years. CDC requests 

approval for an estimated 1,125 annual 

burden hours. There is not cost to 

respondents other than their time to 

participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

U.S. health departments ........................... CureTB Transnational Notification ........... 80 4 30/60 160 

TB patients referred by U.S. health departments.CureTB Transnational Notification ........... 214 1 5/60 18 

Tb patients referred by ICE ...................... CureTB Transnational Notification ........... 587 1 45/60 440 

TB treating physicians in new country ...... CureTB Clinician Public Health Department Follow-up Script.870 3 10/60 435 

U.S. health departments ........................... CureTB Contact/Source Investigation (CI/ 

CS) Notification.

20 5 30/60 50 

U.S. health departments ........................... CureTB Program Partner Satisfaction Assessment Questionnaire 1.100 1 10/60 17 

U.S. health departments ........................... CureTB Program Partner Satisfaction Assessment Questionnaire 2.50 1 6/60 5 

Total ................................................... ................................................................... .................... ........................ .................... 1,125 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–27549 Filed 12–14–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1800–N2] 

Inflation Reduction Act (IRA) Revised 

Program Guidance 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

the availability of CMS’ revised 

guidance for the Medicare Part B and 

Part D Prescription Drug Inflation 

Rebate Program for the implementation 

of the Inflation Reduction Act. CMS will 

be releasing additional Inflation 

Reduction Act-related guidance; all can 

be viewed on the dedicated Inflation 

Reduction Act section of the CMS 

website. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to the revised guidance 

should be sent to IRARebateand 

Negotiation@cms.hhs.gov with the 

relevant subject line, ‘‘Medicare 

Inflation Rebate Program Guidance.’’ 

SUPPLEMENTARY INFORMATION: The 

Inflation Reduction Act was signed into 

law on August 16, 2022. Section 11101 

of the Inflation Reduction Act added a 

new section 1847A(i) to the Social 

Security Act (the Act), which 

establishes a requirement for 

manufacturers to pay Medicare Part B 

rebates for single source drugs and 

biological products with prices that 

increase faster than the rate of inflation 

for a calendar quarter to the Federal 

Supplementary Medical Insurance Trust 

Fund, and provides for lower Part B 

beneficiary cost sharing on these drugs 

and biologicals. Section 11102 of the 

Inflation Reduction Act added a new 

section 1860D–14B to the Act, which 

establishes a requirement for 

manufacturers to pay rebates to the 

Federal Supplementary Medical 

Insurance Trust Fund for certain Part D 

drugs when prices increase faster than 

the rate of inflation for each 12-month 

applicable period. Collectively, this 

program to implement these rebates is 

referred to as the Medicare Prescription 

Drug Inflation Rebate Program, or the 

Inflation Rebate Program. 

To obtain copies of the revised 

guidance and the responses to 

comments from the initial guidance, as 

well as other Inflation Reduction Actrelated documents, please access the 

CMS Inflation Reduction Act website by 

copying and pasting the following web 

address into your web browser: https:// 

www.cms.gov/inflation-reduction-actand-medicare. If interested in receiving 

CMS Inflation Reduction Act updates by 

email, individuals may sign up for CMS 

Inflation Reduction Act’s email updates 

at https://www.cms.gov/About-CMS/ 

Agency-Information/Aboutwebsite/

EmailUpdates. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Vanessa Garcia, who is the 

Federal Register Liaison, to 

electronically sign this document for 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices 86905 

purposes of publication in the Federal 

Register. 

Dated: December 12, 2023. 

Vanessa Garcia, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–27551 Filed 12–14–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–304/–304a, 

CMS–368/–R–144, and CMS–10249] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

February 13, 2024. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–304/–304a Reconciliation of 

State Invoice (ROSI) (CMS–304) and 

Prior Quarter Adjustment Statement 

(PQAS) (CMS–304a) 

CMS–368/–R–144 State Agency 

Contact Form (CMS–368) and 

Quarterly State Invoice (CMS–R–144) 

CMS–10249 Administrative 

Requirements for Section 6071 of the 

Deficit Reduction Act 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Reconciliation 

of State Invoice (ROSI) and Prior 

Quarter Adjustment Statement (PQAS); 

Use: Form CMS–304 (ROSI) is used by 

manufacturers to respond to the state’s 

rebate invoice for current quarter 

utilization. Form CMS–304a (PQAS) is 

required only in those instances where 

a change to the original rebate data 

submittal is necessary. Form Number: 

CMS–304 and –304a (OMB control 

number: 0938–0676); Frequency: 

Quarterly; Affected Public: Private 

sector (business or other for-profits); 

Number of Respondents: 749; Total 

Annual Responses: 5,841; Total Annual 

Hours: 248,584. (For policy questions 

regarding this collection contact Robert 

Giles at 667–290–8626.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program State Reporting Forms; 

Use: Form CMS 368 is a report of 

contact for the State to name the 

individuals involved in the Medicaid 

Drug Rebate Program (MDRP) and is 

required only in those instances where 

a change to the originally submitted 

data is necessary. The ability to require 

the reporting of any changes to these 

data is necessary to the efficient 

operation of these programs. Form 

CMS–R–144 is required from States 

quarterly to report utilization for any 

drugs paid for during that quarter. Form 

Number: CMS–368 and –R–144 (OMB 

control number: 0938–0582); Frequency: 

Quarterly and on occasion; Affected 

Public: State, local, or Tribal 

governments; Number of Respondents: 

56; Total Annual Responses: 290; Total 

Annual Hours: 13,669. (For policy 

questions regarding this collection 

contact Robert Giles at 667–290–8626.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Administrative 

Requirements for Section 6071 of the 

Deficit Reduction Act; Use: State 

Operational Protocols should provide 

enough information such that: the CMS 

Project Officer and other Federal 

officials may use it to understand the 

operation of the demonstration, prepare 

for potential site visits without needing 

additional information, or both; the 

State Project Director can use it as the 

manual for program implementation; 

and external stakeholders may use it to 

understand the operation of the 

demonstration. The financial 


ddrumheller on DSK120RN23PROD with NOTICES1